Use of platforms designed to provide access to individual patient data in order to increase transparency of clinical trial data has been limited, according to a research letter published in the Journal of the American Medical Association.
The study involved 3,255 clinical trials available on three such platforms: ClinicalStudyDataRequest.com, the Yale University Open Data Access Project (YODA), and the Supporting Open Access for Researchers (SOAR) initiative.
Investigators submit a research proposal to the platforms, which is then reviewed, followed by a panel of independent experts approving or rejecting the proposal based on scientific merit and whether the research is designed to meet its goals. A data-sharing agreement is then created.
Of the 234 proposals submitted, 154 were approved and data-sharing agreements completed for 113. The median number of trials requested by each proposal was two. Only 505 unique trials (15.5 percent of available trials) had ever been requested, including 356 phase 3 trials (24.7 percent of phase 3 trials available).
Analytic goals of these proposals varied, including secondary analyses of a trial's treatment effect and analyses of the disease state itself. Validation of the study primary end point was rare (4.4 percent). Only one proposal led to publication; it was a validation study that found contradictory results from the initial article.
The low usage could be attributed to lack of knowledge about these resources, possibly due to lack of publication of results from proposals, or lack of funding to support analyses, the authors concluded.
The need for collaborations with bidirectional data exchange within and across distributed research networks has increased, according to a paper published at eGEMs (Generating Evidence & Methods to improve patient outcomes). At the same time, it points to technical and governance challenges, including the evolution of clinically rich data sources and the processes to share data and link data resources.
An Institute of Medicine report published last year called for a multi-stakeholder effort to further responsible data-sharing for clinical trials and issued a framework for doing so. Meanwhile, a vision of the Library of Medicine's future calls for it to lead efforts to support data sharing and research reproducibility.